SarcopeniaNCT03347656
Effects of Mobility Dose on Discharge Disposition in Critically Ill Stroke Patients
An observational study of Sarcopenia and Stroke, Acute, run by Beth Israel Deaconess Medical Center at 3 sites in 2 countries.
Trial summary
The primary aim of the study is to assess the mobility dose in neurocritical care patients with ischemic stroke or intracranial hemorrhage and its effects on discharge disposition and patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Stroke, Acute, Muscle Weakness
- How many people
- 164 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Oct 2017to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: critically ill stroke patients recovering in the neurological intensive care unit
Who may be able to join
- Aged 18 years and older
- Admitted to the neurological intensive care service within the past 48 hours
- an expected ICU length of stay of at least 48h
- New onset ischemic stroke or non-traumatic intracerebral hemorrhage
- Baseline functional independence: Barthel-Index of 70 or above 2 weeks before admission (obtained retrospectively from patient or proxy)
Who cannot join
- Transfers from other institutions (hospitals, long-term rehabilitation facilities, skilled nursing facilities) with a stay >48h at the outside institution
- absence of lower extremities
- not committed to full support
- exclusive or clinically predominant posterior circulation ischemic stroke
- subarachnoid hemorrhage, subdural and epidural hemorrhage
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215
Germany1 site
Klinikum rechts der Isar of Technische Universität München
Munich, Bavaria
About this study
The primary aim of the study is to assess the mobility dose in neurocritical care patients with ischemic stroke or intracranial hemorrhage and its effects on discharge disposition and patient outcomes. The investigators hypothesize that patients' mobilization dose in the intensive care unit (ICU) predicts discharge disposition, 90 day Barthel Index and other outcomes like muscle wasting (expressed as decrease in rectus femoris cross sectional area (RF-CSA) in the paretic and non-paretic limb measured by bedside ultrasound), and ICU length of stay (LOS).
Read the detailed description
The investigators have previously developed and validated the Surgical Intensive Care Unit Optimal Mobilization Score (SOMS), an algorithm to guide and facilitate early mobilization to advance mobility of surgical intensive care unit patients (NCT01363102). In addition, the investigators have established the use of bedside ultrasound technology to quantify cross sectional area of the rectus femoris muscle, which allows an objective, user-independent quantification of muscle wasting (NCT02270502).
This is a prospective, observational study to observe the relation between mobility dose, muscle wasting and patient outcomes in critically ill stroke patients.
Patients will be enrolled within 48 hours of ICU admission. The investigators will measure the dose of activity, that is duration and intensity of mobilization in critically ill patients with ischemic stroke and intracerebral hemorrhage. By mobility "dose" the investigators are referring to all provider-directed activities (by nursing, and physical therapists) meant to enhance the patient's mobility level. The investigators take into account mobility "dose", defined as a function of both the mobility level (e.g., sitting at the edge of the bed, ambulating) as well as its duration. Of note, there is so far no published data available that describes patients' mobility "dose" in such an integrative, semi-quantitative fashion.
The investigators use the existing mobility intensity quantification tool (MQS) (NCT03196960) and test the hypotheses that mobilization dose predicts muscle wasting in critically ill stroke patients, adverse hospital discharge disposition as well as 90 day Barthel Index. The investigators will apply hierarchical testing to evaluate the association between mobilization dose and discharge disposition as well as 90-day Barthel Index.
The Mobilization Quantification Score (MQS) is a composition of the validated ICU mobility score (SOMS), a 0 to 10 value scale that measures the mobility milestones in critically ill patients, multiplied by a for each level previously defined time unit (5 or 30 minutes correspond to one unit depending on mobilization level).
In order to capture the muscle status at ICU admission, determined by the first bedside ultrasound of the rectus femoris muscle after enrollment, and the change in rectus femoris muscle diameter throughout stay, the investigators will conduct repetitive measurements of the cross sectional area of the rectus femoris muscles (RF-CSA) of both legs. This longitudinal setting will allow to investigate muscle wasting due to immobilization and other severe illness related factors in the paretic and non-paretic limb.
The investigators will conduct a scheduled phone call 30 days and 90 days after hospital discharge by getting in contact with either the patient or a family member to obtain follow-up data. This conversation will include questions that allow to identify the Barthel Index at 30 days, the Barthel Index and GOS-E score at 90 days, and if the patient has been readmitted to a hospital within 30 days of hospital discharge and mortality.
Discharge disposition is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility; or in-hospital mortality. The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease. The GOS-E (Extended Glasgow Outcome Scale) is a global scale for functional outcome that rates patient status into eight categories: Dead Vegetative State, Upper and Lower Severe Disability, Upper and Lower Moderate Disability, Upper and Lower Good Recovery.
- Conditions
- Sarcopenia, Stroke, Acute, Muscle Weakness, Critical Illness
- Keywords
- Mobilization Therapy, Clitical Illness, Stroke, Intensive Care, Functional Mobility, Quality of Life
- Medical subject headings
- Sarcopenia, Stroke, Muscle Weakness, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Hospital Discharge Disposition
Adverse hospital discharge is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility, or in-hospital mortality.
Measured: patient will be followed until hospital discharge; assessed at hospital discharge; expected between study day 3 and 30
90 day Barthel Index (hierarchical testing)
The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease.
Measured: 90 days post discharge from hospital (collected through follow up phone call)
Secondary outcomes (14)
Rectus Femoris Muscle Cross Sectional Area Rectus Femoris Muscle Cross Sectional Area
Rectus femoris cross sectional area will be measured by bedside ultrasound, raw numbers as well as change over time will be respected
Measured: will be measured at least twice (on day of enrollement and before discharge); if stay longer than one week, ultrasound will be performed weekly (every 7 days); expected total time period of 3 to 30 days
30 day Barthel Index
The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease.
Measured: 30 days post discharge from hospital (collected through follow up phone call)
Neurological ICU length of stay
number of days patient stays on the neurological ICU
Measured: admission until discharge from neurological ICU; an expected 3 to 20 days
Neurological ICU length of stay until discharge readiness
number of days patient stays on the neurological ICU until time point from which patient is stable for discharge from ICU
Measured: admission until discharge readiness from neurological ICU; an expected 3 to 20 days
hospital length of stay
number of days patients stays in hospital during index admission
Measured: admission until discharge from hospital: patient will be followed until discharge from hospital; an expected 3 to 30 days
FIM Score at ICU discharge
Functional independence measure score in the domains transfer and locomotion at ICU discharge
Measured: assessed at discharge from neurological ICU; expected between study day 3 and 20
Days on sedation
number of days patient receives sedatives
Measured: during hospital stay; an expected 0 to 30 days
mortality
we will distinguish between ICU mortality, hospital mortality and mortality within 30 or 90 days after discharge from hospital
Measured: during ICU stay, hospital stay or within the 30day or 90day follow up period (follow up data collected through phone call
ICU readmission
readmission to the ICU after discharge from ICU but within hospital stay
Measured: during hospital stay; expected to be assessed between study day 3 and 30
30-day hospital readmission
readmission to a hospital within 30 days after discharge from index stay
Measured: 30 days after discharge from hospital, obtained through follow up phone call
90-day GOS-E (Extended Glasgow Outcomes Scale)
The GOS-E is a global scale for functional outcome that rates patient status into eight categories: Dead Vegetative State, Upper and Lower Severe Disability, Upper and Lower Moderate Disability, Upper and Lower Good Recovery
Measured: obtained 90 days after discharge from hospital through follow up phone call
Total costs of care
total costs of care
Measured: during hospital stay
Falls
number of falls
Measured: during hospital stay; expected to be assessed between study day 3 and 30
Delirium-free days
defined by CAM-ICU (Confusion Assessment Method)
Measured: CAM-ICU will be evaluated daily during hospital stay; an expected 0 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start12 Oct 2017
- Primary completion20 Dec 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Technical University of Munich
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundhar Subramaniam, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347656
- Sponsor's protocol ID
- 2017P000528
- Status last verified
- Aug 2024
- First submitted
- 13 Nov 2017
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.
PubMed 27707496Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.
PubMed 26655919Lee JJ, Waak K, Grosse-Sundrup M, Xue F, Lee J, Chipman D, Ryan C, Bittner EA, Schmidt U, Eikermann M. Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit. Phys Ther. 2012 Dec;92(12):1546-55. doi: 10.2522/ptj.20110403. Epub 2012 Sep 13.
PubMed 22976446Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.
PubMed 22067629Sainsbury A, Seebass G, Bansal A, Young JB. Reliability of the Barthel Index when used with older people. Age Ageing. 2005 May;34(3):228-32. doi: 10.1093/ageing/afi063.
PubMed 15863408Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
PubMed 2240918Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.
PubMed 9726257
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobility Dose on Discharge Disposition in Critically Ill Stroke Patients
- ClinicalTrials.gov ID
- NCT03347656
- Acronym / sponsor ID
- 2017P000528
- Conditions
- Sarcopenia, Stroke, Acute, Muscle Weakness, Critical Illness
- Keywords
- Mobilization Therapy, Clitical Illness, Stroke, Intensive Care, Functional Mobility, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Technical University of Munich
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to assess the mobility dose in neurocritical care patients with ischemic stroke or intracranial hemorrhage and its effects on discharge disposition and patient outcomes. The investigators hypothesize that patients' mobilization dose in the intensive care unit (ICU) predicts discharge disposition, 90 day Barthel Index and other outcomes like muscle wasting (expressed as decrease in rectus femoris cross sectional area (RF-CSA) in the paretic and non-paretic limb measured by bedside ultrasound), and ICU length of stay (LOS).
Detailed description
The investigators have previously developed and validated the Surgical Intensive Care Unit Optimal Mobilization Score (SOMS), an algorithm to guide and facilitate early mobilization to advance mobility of surgical intensive care unit patients (NCT01363102). In addition, the investigators have established the use of bedside ultrasound technology to quantify cross sectional area of the rectus femoris muscle, which allows an objective, user-independent quantification of muscle wasting (NCT02270502).
This is a prospective, observational study to observe the relation between mobility dose, muscle wasting and patient outcomes in critically ill stroke patients.
Patients will be enrolled within 48 hours of ICU admission. The investigators will measure the dose of activity, that is duration and intensity of mobilization in critically ill patients with ischemic stroke and intracerebral hemorrhage. By mobility "dose" the investigators are referring to all provider-directed activities (by nursing, and physical therapists) meant to enhance the patient's mobility level. The investigators take into account mobility "dose", defined as a function of both the mobility level (e.g., sitting at the edge of the bed, ambulating) as well as its duration. Of note, there is so far no published data available that describes patients' mobility "dose" in such an integrative, semi-quantitative fashion.
The investigators use the existing mobility intensity quantification tool (MQS) (NCT03196960) and test the hypotheses that mobilization dose predicts muscle wasting in critically ill stroke patients, adverse hospital discharge disposition as well as 90 day Barthel Index. The investigators will apply hierarchical testing to evaluate the association between mobilization dose and discharge disposition as well as 90-day Barthel Index.
The Mobilization Quantification Score (MQS) is a composition of the validated ICU mobility score (SOMS), a 0 to 10 value scale that measures the mobility milestones in critically ill patients, multiplied by a for each level previously defined time unit (5 or 30 minutes correspond to one unit depending on mobilization level).
In order to capture the muscle status at ICU admission, determined by the first bedside ultrasound of the rectus femoris muscle after enrollment, and the change in rectus femoris muscle diameter throughout stay, the investigators will conduct repetitive measurements of the cross sectional area of the rectus femoris muscles (RF-CSA) of both legs. This longitudinal setting will allow to investigate muscle wasting due to immobilization and other severe illness related factors in the paretic and non-paretic limb.
The investigators will conduct a scheduled phone call 30 days and 90 days after hospital discharge by getting in contact with either the patient or a family member to obtain follow-up data. This conversation will include questions that allow to identify the Barthel Index at 30 days, the Barthel Index and GOS-E score at 90 days, and if the patient has been readmitted to a hospital within 30 days of hospital discharge and mortality.
Discharge disposition is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility; or in-hospital mortality. The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease. The GOS-E (Extended Glasgow Outcome Scale) is a global scale for functional outcome that rates patient status into eight categories: Dead Vegetative State, Upper and Lower Severe Disability, Upper and Lower Moderate Disability, Upper and Lower Good Recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- critically ill stroke patients recovering in the neurological intensive care unit
Key inclusion criteria (5 listed)
- Aged 18 years and older
- Admitted to the neurological intensive care service within the past 48 hours
- an expected ICU length of stay of at least 48h
- New onset ischemic stroke or non-traumatic intracerebral hemorrhage
- Baseline functional independence: Barthel-Index of 70 or above 2 weeks before admission (obtained retrospectively from patient or proxy)
Key exclusion criteria (5 listed)
- Transfers from other institutions (hospitals, long-term rehabilitation facilities, skilled nursing facilities) with a stay >48h at the outside institution
- absence of lower extremities
- not committed to full support
- exclusive or clinically predominant posterior circulation ischemic stroke
- subarachnoid hemorrhage, subdural and epidural hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse Hospital Discharge Disposition
Time frame: patient will be followed until hospital discharge; assessed at hospital discharge; expected between study day 3 and 30
Adverse hospital discharge is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility, or in-hospital mortality.
90 day Barthel Index (hierarchical testing)
Time frame: 90 days post discharge from hospital (collected through follow up phone call)
The Barthel Index is a measure of functional disability originally designed to evaluate progress of rehabilitation in patients with stroke and neuromuscular disease.
14 secondary outcomes
Rectus Femoris Muscle Cross Sectional Area Rectus Femoris Muscle Cross Sectional Area
Time frame: will be measured at least twice (on day of enrollement and before discharge); if stay longer than one week, ultrasound will be performed weekly (every 7 days); expected total time period of 3 to 30 days
30 day Barthel Index
Time frame: 30 days post discharge from hospital (collected through follow up phone call)
Neurological ICU length of stay
Time frame: admission until discharge from neurological ICU; an expected 3 to 20 days
Neurological ICU length of stay until discharge readiness
Time frame: admission until discharge readiness from neurological ICU; an expected 3 to 20 days
hospital length of stay
Time frame: admission until discharge from hospital: patient will be followed until discharge from hospital; an expected 3 to 30 days
FIM Score at ICU discharge
Time frame: assessed at discharge from neurological ICU; expected between study day 3 and 20
Days on sedation
Time frame: during hospital stay; an expected 0 to 30 days
mortality
Time frame: during ICU stay, hospital stay or within the 30day or 90day follow up period (follow up data collected through phone call
ICU readmission
Time frame: during hospital stay; expected to be assessed between study day 3 and 30
30-day hospital readmission
Time frame: 30 days after discharge from hospital, obtained through follow up phone call
90-day GOS-E (Extended Glasgow Outcomes Scale)
Time frame: obtained 90 days after discharge from hospital through follow up phone call
Total costs of care
Time frame: during hospital stay
Falls
Time frame: during hospital stay; expected to be assessed between study day 3 and 30
Delirium-free days
Time frame: CAM-ICU will be evaluated daily during hospital stay; an expected 0 to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 27707496Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.
- Background: PubMed 26655919Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.
- Background: PubMed 22976446Lee JJ, Waak K, Grosse-Sundrup M, Xue F, Lee J, Chipman D, Ryan C, Bittner EA, Schmidt U, Eikermann M. Global muscle strength but not grip strength predicts mortality and length of stay in a general population in a surgical intensive care unit. Phys Ther. 2012 Dec;92(12):1546-55. doi: 10.2522/ptj.20110403. Epub 2012 Sep 13.
- Background: PubMed 22067629Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.
- Background: PubMed 15863408Sainsbury A, Seebass G, Bansal A, Young JB. Reliability of the Barthel Index when used with older people. Age Ageing. 2005 May;34(3):228-32. doi: 10.1093/ageing/afi063.
- Background: PubMed 2240918Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
- Background: PubMed 9726257Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balachundhar Subramaniam, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Stroke, Acute, run by Beth Israel Deaconess Medical Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Hospital Discharge Disposition (time frame: patient will be followed until hospital discharge; assessed at hospital discharge; expected between study day 3 and 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347656, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.